Washington, DC: Following reports of 70 incidents in which the Abbott-Thoratec HeartMate II LVAS Pocket System Controller has malfunctioned after an exchange, a Class 1 recall has been issued for the device.
The 70 incident reports include 19 injuries and 26 deaths. All of the deaths occurred when patients attempted to exchange controllers while away from the hospital, the US Food and Drug Administration said in a news release.
The Pocket System Controller is a power supply that connects to the implanted HeartMate II LVAS pump through a lead (driveline) under the skin. The controller helps power the LVAS system, a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
The controller is powered by batteries or connected to a main power supply. The HeartMate II LVAS Pocket System Controller is intended for use inside or outside of the hospital. A back-up system controller is provided to each patient for use in case of a device alarm or malfunction. Instructions and training are provided on how to switch from one system controller to the other. Model/Item Numbers recalled are: 105109, 106015, 106762, 107801 and Manufactured July 2012 to December 2016. The recall was initiated March 30, 2017.